Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia

NCT ID: NCT06348095

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-27

Study Completion Date

2024-12-31

Brief Summary

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To evaluate the effectiveness and safety of compound probiotic in shortening the course of illness in children with mycoplasma pneumoniae pneumonia, in comparison with placebo.

Detailed Description

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Conditions

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Mycoplasma Pneumoniae Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Probiotics group

2B CFU/ strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).

Placebo group

Maltodextrin, one strip/ day WecProB, before meals; Storage: Store in a cool, dry place without sun exposure.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).

Interventions

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Probiotic

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).

Intervention Type DIETARY_SUPPLEMENT

Placebo

The experimental phase of this study had last 14 days, and each patient will make 4 visits (d0, d3, d7, d14).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Meet the diagnostic criteria for pneumonia in "Zhufutang Practical Pediatrics" (7th Edition), and is diagnosed with Mycoplasma pneumoniae pneumonia using tNGS technology;
2. Infants and young children aged 6 months to 3 years;
3. The course of the disease is \<48 h;
4. The family members of the children are informed about the study and sign the informed consent form.

Exclusion Criteria

1. Previous history of wheezing;
2. Cardiovascular disease and congenital tracheal dysplasia;
3. pneumonia induced by other causes;
4. Dysplasia of bronchial and pulmonary tracts;
5. premature infants;
6. Combined with immunosuppressive diseases;
7. Presence of mental illness.
Minimum Eligible Age

6 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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WK2024004

Identifier Type: -

Identifier Source: org_study_id

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